Effect of intra-dialytic neuromuscular electrical stimulation and oral nutritional supplements in hemodialysis patients, a randomized-controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005573

Enrollment

Registered

2020-11-03

Start date

2020-11-02

Completion date

Unknown

Last updated

2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Dietary Supplement : This clinical trial was randomly assigned to three test groups (electrical stimulation during dialysis, protein-based nutritional supply group, and protein-based n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Stable patients with end-stage renal disease undergoing dialysis for more than 3 months -Patients suspected of protein energy wasting with serum albumin <4.0 g/dL -Patients who can understand the study

Exclusion criteria

Exclusion criteria: -Acute kidney injury -Patients with uncontrolled hypertension, diabetes, or heart failure -Patients with AST(GOT) or ALT(GPT) 3 times or more than the upper normal limit of the test institution -Patients diagnosed with hematologic or solid cancer undergoing treatment -Patients with active infection -HIV positive patients -Patients with a history of ischemic heart disease, stroke, deep vein thrombosis within 3 months -Patients planning a kidney transplantation within 3 months -Patients with limited electrical stimulation, such as implantable cardioverter-defibrillators -Patients with skin lesions at the electrical stimulation site -Patients allergic to protein supplements -Patients who have participated in other clinical trials within 2 months of the start of this clinical trial or plan to participate in other clinical trials during this human application trial period -Pregnant woman -Patients who judge that the investigator is inappropriate for participating in this clinical trial, such as poor understanding of this clinical trial due to old age, etc.

Design outcomes

Primary

Measure	Time frame
Physical signs, blood tests, nutrition-related indicators, muscle strength evaluation, body composition analysis, physical function evaluation, quality of life evaluation, physical activity evaluation, fall efficacy scale, depressed mood evaluation	—

Countries

Korea, Republic of

Contacts

Public ContactJae Yoon Park

Dongguk University Ilsan Hospital

nephrojyp@gmail.com+82-31-961-7273

Outcome results